Who is the manufacturer of TAKE 1 BITE?

Sybron Dental Specialties, Inc. submitted the Traditional clearance for TAKE 1 BITE (K001876).

What is the FDA product code for TAKE 1 BITE?

ELW. It is classified under 21 CFR 872.3660 as a Class 2 device in the Dental panel.

What is the regulatory pathway for TAKE 1 BITE?

510(k) clearance (submission type: Traditional).

TAKE 1 BITE

K001876 · Sybron Dental Specialties, Inc. · ELW · Jul 21, 2000 · Dental

Device Facts

Record ID	K001876
Device Name	TAKE 1 BITE
Applicant	Sybron Dental Specialties, Inc.
Product Code	ELW · Dental
Decision Date	Jul 21, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3660
Device Class	Class 2

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).